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Case number 24-5262, Jazz Pharmaceuticals Inc.

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Appellants, versus Robert F. Kennedy Jr., Secretary of the Department of Health and Human Services and Health.

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Mr. Akua for the Appellants, Mr. Springer for the Defendant Appellees, Mr. Jerry for the Intervener Appellees.

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Mr. Akua, go ahead.

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Thank you.

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Thank you, Dr. Henderson.

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May it please the court, Kwakuwakoa for Jazz Pharmaceuticals.

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The Orphan Drug Act seeks to encourage businesses to invest in developing treatments for some 7,000 rare diseases, many very serious, that collectively afflict about 30 million Americans.

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FDA's rare disease website states that there are no drug treatments for most of those rare diseases, and one prominent advocacy group pegs the share at 90%.

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Now, the Act chiefly takes aim at that problem by creating a period of marketing exclusivity for companies that win approval for an innovative rare disease treatment, a seven-year period.

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during which FDA quote, may not approve certain other new drug applications.

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And of course, the party's dispute is over which of those new drug applications is barred.

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Now, we think it's not just the scope of the prohibition, but really the nature of it that's at issue here.

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We say that the ordinary meaning of the statute's text and grammar resolve that question.

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And they do so in a way that makes the prohibition fixed and predictable and thus well suited to spur business investment because it's pegged to the designation decision that FDA makes before the drug maker even submit the application for approval.

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It so ties the agency's hands by temporarily barring it from approving another application that would use the same designated drug to treat the same rare disease.

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And that comes straight from subsection A of the statute, which provides that if FDA approves an application, quote, for a drug designated under section 360 double B of this title for a rare disease or condition, unquote, then for a period of seven years, FDA may not approve another application.

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Here's its second quoted phrase, for the same drug, for the same disease or condition.

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And in those parallel phrases, for the same drug, refers back to the antecedent for a drug designated

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under section 360 double B. And so the same drug, the thing the agency is temporarily barred from approving, is the drug previously designated for the approved application.

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And Congress's directive is just that simple.

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Now, my friends on the other side, offer, Judge Wilkins?

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Yeah, I'd like to interrupt.

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I want to kind of get down to the press, perhaps.

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Sure.

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What do you think the impact of the 2017 amendment is?

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What do you think it does?

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It has to do something.

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What do you think it does?

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So the 2017 amendments, we think, and the tax reflects this, are focused on the deep emit issue.

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So when there's already been one approval for a designated drug to treat a particular disease or condition, in what circumstances can there be a second or successive seven-year period of marketing exclusivity?

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That's what the 2017 amendments are all about.

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So if that's the case,

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I want you to tell me where in the designation section, that's 21 USC section 360 BE, there is anything in that statute that says that in order for a drug to be designated, not approved, designated,

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that it has to have some sort of clinical superiority.

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Where does that appear in the statute in 3360 BB for designation?

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Sorry, that there must, for designation purposes, where in the statute does it say there must be a demonstration of clinical?

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Yeah, let me ask it this way.

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The statute for designation of drugs for rare diseases or condition basically says that if the FDA finds that this is a rare disease or condition that is to be treated by this drug that the sponsor is seeking to have designated, if they find that it is indeed a rare disease or condition, and that if approved, this will treat that rare disease,

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or condition, they shall approve the designation.

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That's right.

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There's nothing in there that says that it also has to be clinically superior if it's the same drug.

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None of that language is in the designation provision, right?

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So the designation provision does include a requirement that the follow-on drug demonstrate a possible hypothesis.

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That's in the 2017 amendment, right?

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Yes.

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In the 2017 amendment, amends 360 CC.

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The approval that doesn't amend 360 BB designation

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I think I'm losing the thrust of your honor's question.

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Let me just make it plain to you.

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Sure.

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I'm not playing poker here.

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I want you to understand what my concern is.

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Sure.

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It's why right now I'm inclined to say that I think that you lose.

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So let me lay it out and then you can respond.

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Sure.

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The FDA, prior to 2017, had a regulation, which is at 21 CFR 316.25.

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It says that you can't get designation for the same drug

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as one that's been previously designated and approved for treatment of a rare disease or condition, unless it's clinically superior.

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As best as I can tell, prior to 2017, there was nothing in the statute that allowed the FDA to place that limitation on designation.

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I understand.

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So if you follow the logic of depo-med in legal pharmaceuticals, that regulation would be ultra-variant.

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I think I am.

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But it appears that with the 2017 amendment, by what you say the work that it does, the FDA has appeared to have blessed

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this way that designation works under the prior regulatory scheme by saying that, well, you can have an additional condition on whether something can be designated in restriction, let's say, on whether something can be designated.

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if a prior drug had been designated in approval, which is otherwise the same drug.

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So if Congress was approving or sanctioning or incorporating or ratifying whatever word we want to use,

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that aspect of the pre-2017 regulatory scheme, then why should we conclude that they weren't also approving or ratifying the other aspect at the approval stage?

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of what the FDA was doing prior to 2017 with respect to exclusivity.

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Can I make myself clear?

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You did, Your Honor.

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And let me see if I can answer.

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I think that the text helps us tremendously, and that also the statutory history helps us tremendously.

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And so on the text, what you have is Congress picking up this idea that FDA had, that there ought to be

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limits on what they called serial exclusivity.

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So there's already been a drug for a same drug for the same disease or condition that's been approved.

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In what circumstances does it make sense to give the next drug also a period of exclusivity and essentially the what subsection C, D, and E reflect?

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Are Congress grappling with that question?

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and saying, it's got to be new innovation, so a clinically superior drug.

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Now, Your Honor's question is, well, why wouldn't they have also done that in subsection A?

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One answer is, you don't see in subsection A anything like the reticulated description of how clinical superiority should operate at the approval stage, the marketing exclusivity stage.

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to allow FDA to say, well, actually, seven years, we're going to break into it.

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You don't see the words clinical superiority there.

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You don't see them say, we have two exceptions, and B, we'll have to add a third exception.

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And so you just don't have a mirror image of the careful attention they paid to serial exclusivity paid to the other question.

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And everyone agrees that FDA had this idea

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as well that they could break through existing unexpired periods of exclusivity, but you don't see that reflected in the 2017 amendment at all.

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You also don't see that coming to statutory history.

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in the discussion of what Congress was doing.

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And I want to grant that that was what we have is very limited.

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But let me take you through what I think is telling.

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I read Deepamed to announce three criticisms of FDA's approach.

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One, that they issued regulations for 360CC

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without statutory authority.

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And that was subsections A and B that existed at the time.

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And one distinction, Judge Wilkins, to 360 BB, the prior statute, is that statute has and has long had express authority for FDA to promulgate regulations.

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And so it's indicative of policymaking in that part of the statute.

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So I guess the bottom line, though, is Congress chose to use the term same drug, which has a definition in the regulations

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And also, it seems that that's a longstanding policy to treat such drug as same drug.

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And it also seems that Congress must have been aware of the same drug definition.

[00:12:24] Speaker 07:
But you're trying to tell us that Congress didn't mean to incorporate the same meaning of same drug that's defined by the regulation.

[00:12:32] Speaker 04:
That's right, because I don't think the text takes you there at all.

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I mean, the Supreme Court has said in yellow line versus confederated tribes.

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Linguistic similarity is not enough.

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When this court has looked at ratification, take Judge Henderson's decision in genus, it said express approval is what the court looks to.

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New York versus EPA, the court said when Congress doesn't expressly cross-reference an existing regulation that cuts sharply against

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the inference of ratification.

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That read back to a case called Continental Airlines, where Congress had used commuter airlines, same phrase that the agency had used the Civilian Aeronautics Board.

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And this court said the mere overlap isn't enough.

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So this court's always looked to more when an agency says there's ratification.

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And then to come back to the deep in that history, Judge Jackson called out this issue.

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She said that the logic of the statute is that the grant of the seven-year period precludes subsequent approvals for what she called new and better drugs.

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So that's right there.

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And then she calls out as well the serial exclusivity limitation and says,

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FDA didn't have authority to do that.

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The way I read the 2017 statute is Congress only addressed the third of those points.

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It didn't provide any rule-writing authority for subsections A and B, which were what Judge Jackson had in front of her.

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It didn't address whether FDA could rely on clinical superiority to make a

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breakthrough determination.

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It's nowhere in subsection A. It didn't add subsections.

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And then it turned to subsection D, and it said, we're going to put some limits on how FDA uses its old regulations.

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So there, there's a permanent grant of authority, right regulations for the implementation of subsection C, serial exclusivity, not our breakthrough unexpired approval context.

[00:14:44] Speaker 07:
It says, then you can use those, the old, the definitions in the old- When we look at the context though, I guess this comes back to Judge Wilkins's first question.

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Congress specifically put the word same drug.

[00:14:57] Speaker 04:
Right, right.

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And so then- And so we're like, well, what did they mean to do by that?

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And it just seems, it seems that the most likely answer is that they were using the definition of same drug that's in the regulation and intended to make it clear

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that such drug means same drug.

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It would be very confusing for them to use the word same drug and not mean what everybody has understood same drug to mean in this context.

[00:15:23] Speaker 04:
And the proof that they didn't mean to use the same drug in the way the FDA had is in subsection C1.

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So at the end of subsection C1, Congress talks about this very relationship between clinical superiority and the same drug.

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And it says that to get the serial exclusivity, you have to show that the follow-on drug is clinically superior to any approved or licensed drug that is the same drug.

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That is, Congress is thinking about those two drugs as being the same.

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And nonetheless, one is entitled to a period of serial exclusivity.

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That's how they were contemplating the same drug.

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And I think that's because they're contemplating it in the same textual terms that you see

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in subsection A. It can't possibly mean the same drug unless the second one is superior to the first at the end of subsection C. And so Judge Maeda's answer to that was, you're right.

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The same drug definition can't possibly plug in there.

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But that just means that the same drug means something different there than it means elsewhere.

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And that should really set your alarm bells off, because in the ordinary course,

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in two closely related provisions of a statute, Congress is going to use a term in the same way.

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And if it's ratifying, what we have is the similarity between how FDA, those three words, the same drug, in the regulation in the statute.

[00:16:54] Speaker 08:
Let me ask you this.

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So in the exclusive approval statute, 360 CC subsection A. Yes.

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if the drug has been previously designated under 360 BB?

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Yes.

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And then it is subsequently approved under section 355?

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Yes.

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Is there authority for the FDA to approve it, but to not grant it exclusive approval?

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if it has been designated under 316BD?

[00:17:45] Speaker 04:
The limit comes from subsection C. So if under subsection C, the sponsor is seeking an exclusive approval for a drug that is a drug that's the same and for the same rare disease condition as the already approved drug, then

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the secretary may not grant the exclusive approval under A, unless the clinical superiority requirement is met.

[00:18:15] Speaker 08:
So that's- So prior to 2017, the 2017 amendments, did the FDA have the authority to grant non-exclusive approval

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when it approved a drug under section 355 that had been designated previously under 360 BB?

[00:18:45] Speaker 04:
No, so Deepa Med and EGLE said, this is simple.

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If designated and approved, then exclusivity follows.

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And it rejected FDA's understanding, interpretation that there was a clinical superiority limitation.

[00:19:02] Speaker 04:
And then of course Congress between deeper mad and eagle steps in and says subsection C. Here's the here's the here's the limit.

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You can in fact do what FDA had in mind before, but I think the important point is that for our purposes, when they

[00:19:21] Speaker 04:
grabbed onto this issue, they said, let's talk about it.

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Here's subsection C. Here's D. Here's E. Let's talk about it in our terms.

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And they used the same drug.

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Again, this is one of our most powerful textual points.

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They used the same drug in a way that can't possibly have the meaning that FDA had ascribed to it in regulation.

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The other key here in terms of context is that the

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The definition of clinical superiority that they use is maybe not be completely verbatim, but it's pretty much taken from the FDA's regulation.

[00:20:07] Speaker 04:
Yes, absolutely.

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And actually, I think that cuts our way.

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Because if they were using the same drug,

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in the way that FDA had used it, clinical superiority in this definition would just flow right with it.

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Instead, they're using the same drug in a way that requires a separate definition of what clinical superiority is because they don't think it comes from the same drug.

[00:20:30] Speaker 04:
They think they have to say it.

[00:20:32] Speaker 07:
It sounds like your argument is that subsection C is confusing.

[00:20:36] Speaker 04:
That doesn't mean subsection A is confusing.

[00:20:39] Speaker 04:
I don't think subsection C is confusing.

[00:20:40] Speaker 04:
I think subsection C makes no sense if you read it the way that they want to read it.

[00:20:46] Speaker 04:
You can't plug the same drug in to subsection C. But if you read subsection C, just as it is with an ordinary language frame, and you say, oh, subsection C is where Congress did the thing that Judge Jackson said in Deepa Med they couldn't do.

[00:21:03] Speaker 04:
It can limit the grant of serial exclusivity.

[00:21:05] Speaker 04:
Subsection C1 says what that limit is.

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C2 provides an operational definition.

[00:21:12] Speaker 04:
D tells you how the regulations can be used.

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E tells you when to publish.

[00:21:15] Speaker 07:
It just seems like because subsection C wasn't drafted very clearly, you're trying to say subsection A must mean a particular meaning.

[00:21:23] Speaker 04:
Not at all.

[00:21:24] Speaker 07:
But I don't know that that's necessarily true.

[00:21:26] Speaker 00:
Not at all, Your Honor.

[00:21:26] Speaker 07:
We have a regulatory definition.

[00:21:29] Speaker 07:
So in your framework, what do we do with this regulatory definition of what same drug is?

[00:21:35] Speaker 04:
I don't think there's a role for the regulatory definition of same drug.

[00:21:40] Speaker 04:
Oh, really?

[00:21:41] Speaker 07:
So we're going to write that out of the statutory structure?

[00:21:46] Speaker 04:
In subsection A, because subsection A tells you what the same... Well, anywhere.

[00:21:50] Speaker 07:
I think you're saying subsection C and subsection A have to be read a certain way.

[00:21:54] Speaker 07:
I'm asking you, what is the role for the definition under 316.314?

[00:22:01] Speaker 07:
there's a definition of what same drug means.

[00:22:03] Speaker 07:
What's the role for that in your interpretation?

[00:22:06] Speaker 04:
Correct.

[00:22:06] Speaker 04:
So I don't think it has a role in 360 CC.

[00:22:09] Speaker 04:
Does it have a role anywhere?

[00:22:11] Speaker 04:
I think it may well have a role elsewhere in the statute.

[00:22:16] Speaker 04:
My argument is focused on what.

[00:22:19] Speaker 07:
I understand that.

[00:22:20] Speaker 07:
But for your argument to make sense, it has to make sense in the entire statutory system.

[00:22:24] Speaker 04:
I don't think so.

[00:22:25] Speaker 04:
And here's what.

[00:22:25] Speaker 04:
Subsection D, which I alluded to, is Congress saying

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You can't, to the extent that definitions that FDA used to use are inconsistent with the terms of this section as amended by this act, you can't use them.

[00:22:39] Speaker 07:
I thought it says you may apply definitions set forth.

[00:22:42] Speaker 04:
To the extent such definitions are not inconsistent.

[00:22:47] Speaker 04:
If they're inconsistent, subsection D says they fall away.

[00:22:51] Speaker 07:
I think my bottom line, the question I'm trying to ask you is, your interpretation is less likely to be correct

[00:22:58] Speaker 07:
if you're trying to tell us that Congress sub-silencio decided to excise the definition of same drug from the statutory scheme.

[00:23:07] Speaker 07:
And I'm trying to understand what is the role for this definition under your interpretation.

[00:23:13] Speaker 04:
The regulatory definition didn't define same drug in the statute.

[00:23:18] Speaker 04:
The statute didn't say

[00:23:19] Speaker 04:
same drug when FDA wrote the regulations.

[00:23:24] Speaker 07:
So same drug comes into- Which is why it seems like a logical interpretation of what Congress did was they understood that the FDA has been using such drug to mean the regulatory definition of same drug.

[00:23:38] Speaker 07:
So we're going to put that in and make it clear that same drug is what they've been doing all along.

[00:23:43] Speaker 07:
And you're trying to say, no, they've decided to

[00:23:46] Speaker 07:
require a completely different approach, but using the same words.

[00:23:50] Speaker 04:
And I grant there is that overlap of language.

[00:23:58] Speaker 04:
It gives rise to, well, why aren't they borrowing it?

[00:24:01] Speaker 04:
But then the analysis, Yellen tells us, Johnson tells us, Genus tells us, does it fit?

[00:24:09] Speaker 07:
I understand that you can construct an argument for this, but why is that the best reading of this?

[00:24:14] Speaker 07:
given the statutory context, and Congress being aware, we have to assume that Congress was aware of the statutory context, and they chose to put in the words that everybody understands what the meaning of the word same drug means.

[00:24:29] Speaker 07:
And that's the meaning that the agency has been applying for all this time.

[00:24:33] Speaker 07:
It just seems like the more logical interpretation is they were trying to make it official, what the agency has been doing all along, as opposed to upend what the agency has been doing all along, while using the same words and definition that the agency has been using all along.

[00:24:46] Speaker 04:
I understand that, Judge Pan.

[00:24:48] Speaker 07:
If you plug the same drug into a— I understand the analysis, but why is that a better way of reading it than what I just said?

[00:24:55] Speaker 04:
There's no case that I've ever seen, none my friends cite, in which a ratification definition flips the valence of a statute.

[00:25:02] Speaker 04:
So subsection A is all about a prohibition.

[00:25:06] Speaker 04:
Thou shalt not.

[00:25:07] Speaker 04:
In their terms,

[00:25:09] Speaker 04:
The same drug creates a giant grant of discretion to the agency to decide to approve drugs notwithstanding may not approve.

[00:25:20] Speaker 04:
I've never seen a statute.

[00:25:22] Speaker 04:
I've never seen a case describe a statute as doing that.

[00:25:27] Speaker 04:
fundamentally flip around the policy of the act.

[00:25:30] Speaker 04:
And the one thing we have from the legislative history.

[00:25:32] Speaker 07:
I can't think of a statute off the top of my head, but there are often terms that have meanings that are beyond the plain meaning on the page.

[00:25:38] Speaker 07:
There are lots of statutory contexts and structures where a meaning is taken on from other parts or the context.

[00:25:46] Speaker 07:
And here, that's what we have.

[00:25:48] Speaker 04:
But I don't think that's the context.

[00:25:51] Speaker 04:
The context is Congress saying, with a business investment goal in mind, we want to induce people to invest.

[00:26:00] Speaker 04:
We're going to tie the agency's hands for a seven-year period so that it can't approve.

[00:26:06] Speaker 07:
And they balance that with, if there's a drug that's better for consumers and patients and people, if it's clinically superior, we are going to allow that because it's good in the grand scheme.

[00:26:16] Speaker 07:
So they're trying to balance encouraging the drug to be developed while also not making sure that better drugs are going to be kept out of the market, because that's not good for patients.

[00:26:27] Speaker 04:
But remember, there really is a balance here.

[00:26:31] Speaker 04:
My friends are focused only on the sort of follow-on drug portion of the balance.

[00:26:35] Speaker 04:
They're not focused where I started on there are thousands of drugs or thousands of diseases affecting millions of Americans that have no drug treatment.

[00:26:45] Speaker 04:
The goal is to induce investment for those diseases.

[00:26:52] Speaker 04:
And a business person is going to say, well, OK, great.

[00:26:55] Speaker 04:
What do I get?

[00:26:55] Speaker 04:
The drug's designated, and it's approved.

[00:26:58] Speaker 04:
What do I get?

[00:26:58] Speaker 07:
And the lawyer's- But there's a chance that nobody's going to come up with a clinically superior drug, and then you've got the whole seven years.

[00:27:03] Speaker 07:
But if somebody does, you're taking that risk.

[00:27:05] Speaker 04:
They're already taking on enormous risk.

[00:27:09] Speaker 04:
And what Congress was trying to create was a sense of certainty.

[00:27:12] Speaker 07:
But clearly, all the drug makers know about the definition of same drug and the way such drug has been interpreted all these years.

[00:27:19] Speaker 04:
And through all these years, Judge Pan, up to 2017.

[00:27:22] Speaker 04:
And here, I keep trying to talk about the context around DeepMed.

[00:27:27] Speaker 04:
And DeepMed, of course, is all about serial exclusivity.

[00:27:31] Speaker 04:
FDA had barely done these kind of breakthrough applications of the statute.

[00:27:37] Speaker 04:
They claimed the authority to do it.

[00:27:39] Speaker 04:
We found in the administrative record reveals four instances, the last in 2002.

[00:27:44] Speaker 04:
That's why I don't think Congress was thinking about this application.

[00:27:47] Speaker 04:
It was thinking about what was in litigation, what FDA said in a post-DEPA med statement that's published in the Federal Register.

[00:27:58] Speaker 04:
We grabbed that.

[00:28:00] Speaker 04:
for your honors.

[00:28:01] Speaker 04:
I'll find it when I stand back up.

[00:28:06] Speaker 04:
But what they said was, we have a huge problem here.

[00:28:10] Speaker 04:
We need the ability to limit serial grants of exclusivity.

[00:28:14] Speaker 04:
They went to Congress.

[00:28:16] Speaker 04:
We don't know exactly what FDA said to Congress.

[00:28:18] Speaker 04:
But what the legislative history reflects is a member of Congress saying, here's what we understand.

[00:28:27] Speaker 04:
this change to do is to address the serial exclusivity problem while maintaining incentives to innovate.

[00:28:36] Speaker 07:
I don't think Congress thought they were touching- But you still have an incentive to innovate because you don't know that somebody's going to come up with a clinically superior drug.

[00:28:44] Speaker 04:
You don't know, but you've clearly inserted more risk into what's already a risk endeavor.

[00:28:52] Speaker 07:
But isn't that the way it always was before?

[00:28:54] Speaker 04:
And that's what they'd barely done.

[00:28:57] Speaker 07:
So all of the, I'm sorry, are you telling me, my understanding is that before this amendment, it said such drug.

[00:29:05] Speaker 07:
But the agency interpreted that to mean the same drug as it's defined, which includes clinically superior.

[00:29:12] Speaker 07:
clinically superior aspect of it.

[00:29:14] Speaker 07:
Didn't all the drug companies know that?

[00:29:17] Speaker 04:
They knew that FDA had claimed that authority.

[00:29:21] Speaker 04:
In 2017, they would have known that... That's something you have to take into account before you start investing and developing... And in 2017, they would have known that had been 15 years, FDA hadn't done it.

[00:29:34] Speaker 04:
And now if someone goes... I'm sorry, 15 years, FDA has not applied this definition?

[00:29:39] Speaker 04:
From 2002,

[00:29:41] Speaker 04:
To 2017, so far as the administrator record reveals, FDA did not use the such drug, same drug move to break through an unexpired period of exclusivity.

[00:29:54] Speaker 04:
So Judge Jackson.

[00:29:55] Speaker 08:
Let me ask you.

[00:29:58] Speaker 04:
So you're saying that from 2002 to when?

[00:30:02] Speaker 04:
So up to 2017 when Congress revises the statute, right?

[00:30:08] Speaker 08:
So you're saying that

[00:30:10] Speaker 08:
that in 2017, you believe that the statute, that change does not allow you to break the exclusivity period.

[00:30:22] Speaker 04:
Absolutely.

[00:30:22] Speaker 08:
Let me just make sure I understand the record in what the district court said in its opinion.

[00:30:31] Speaker 08:
In going through the history of these drugs, it said that your client

[00:30:41] Speaker 08:
received approval for a drug called Xiram initially in 2002.

[00:30:49] Speaker 08:
And then in 2005, it got approved Xiram for a new indication.

[00:31:00] Speaker 08:
And then in 2018, the FDA approved Xiram for the treatment

[00:31:08] Speaker 08:
of EDS or cataplexy in narcolepsy patients seven years or older.

[00:31:14] Speaker 08:
That's at page 15 of the district court's opinion, JA 548.

[00:31:19] Speaker 08:
Is that all correct?

[00:31:22] Speaker 08:
Do I understand the guess?

[00:31:24] Speaker 08:
And so then ZYRAJAS develops a low sodium alternative to ZYRIM.

[00:31:34] Speaker 08:
And that's the drug that's at issue here, this ZYWAVE, right?

[00:31:39] Speaker 08:
That's right.

[00:31:40] Speaker 08:
And it gets approval in 2020.

[00:31:47] Speaker 08:
And it gets exclusivity based on the finding that it's clinically superior because it's low sodium, right?

[00:31:56] Speaker 08:
Yes.

[00:31:58] Speaker 08:
So doesn't ZyWave

[00:32:04] Speaker 08:
essentially break the exclusivity period that had been established in 2018 of ZYRIM.

[00:32:14] Speaker 04:
No.

[00:32:17] Speaker 04:
So subsection A is clear that it limits only approvals for a person who is not the holder of such approved application or such license.

[00:32:30] Speaker 04:
So Congress is not tying the hands of FDA as to the same sponsor.

[00:32:36] Speaker 04:
You get one exclusive approval.

[00:32:39] Speaker 04:
It doesn't bar that same company from getting another approval.

[00:32:43] Speaker 04:
it operates as to other companies.

[00:32:47] Speaker 04:
But I do want you touched on the approval for different indications.

[00:32:52] Speaker 04:
And I think this is another indication that Congress was not using same drug as FDA had.

[00:33:00] Speaker 04:
The FDA's action words were same drug for the same user indication.

[00:33:05] Speaker 07:
Let me go back to what Judge Wilkins just said.

[00:33:07] Speaker 07:
I want to make sure I understand this.

[00:33:10] Speaker 07:
It seemed like what he described was

[00:33:14] Speaker 07:
an application of the same drug definition from the regulation to this context.

[00:33:20] Speaker 07:
You said that hadn't been done between 2002 and 2017.

[00:33:25] Speaker 07:
And it seems like they said they gave a new period of exclusivity because it was clinically superior.

[00:33:31] Speaker 07:
So that's a new drug.

[00:33:33] Speaker 07:
So if somebody else other than your client had done it, would they be entitled to the same thing that your client got?

[00:33:41] Speaker 04:
So two distinctions, maybe three.

[00:33:45] Speaker 04:
One is Judge Wilkins was asking about a 2020 occurrence, so a 2020 approval, not 2017.

[00:33:52] Speaker 04:
Two, it's not an application of the same drug definition in the regulations.

[00:33:58] Speaker 04:
It's an application of subsection C, which by then was on the books.

[00:34:04] Speaker 04:
So that's exactly what subsection C. One says, is there any

[00:34:09] Speaker 04:
already approved licensed drug that's the same.

[00:34:11] Speaker 04:
Yes, because ZyWave, the new drug, and Zyrem, the prior approved drug, both use Oxabate.

[00:34:18] Speaker 07:
That's otherwise the same.

[00:34:20] Speaker 04:
That's otherwise the same.

[00:34:21] Speaker 04:
That's otherwise the same at the designation level.

[00:34:24] Speaker 04:
And so in order to gain an exclusive approval, so a marketing exclusivity, ZyWave, Jazz had to demonstrate that ZyWave was clinically superior

[00:34:34] Speaker 04:
to use IRM under the definition of C2.

[00:34:38] Speaker 04:
That's why Judge Pan, I don't think there's anything confusing about C1 if you just read the words for the words.

[00:34:43] Speaker 04:
The confusion comes in when you try to do what they're doing and say, oh, well, the same drug has the old regulatory meaning.

[00:34:51] Speaker 04:
Well, actually, it doesn't have the old regulatory meaning.

[00:34:53] Speaker 04:
Actually, it creates surplusage.

[00:34:54] Speaker 04:
All those problems come in when you depart from the plain tax and go down the ratification worm.

[00:35:02] Speaker 04:
red on its face.

[00:35:03] Speaker 04:
This is a very simple statute.

[00:35:05] Speaker 07:
So let me make sure I understand you.

[00:35:06] Speaker 07:
Are you saying that even though it has been presented to us that the long standing understanding of such drug was that it equals same drug

[00:35:16] Speaker 07:
Are you saying that that actually isn't the long-running understanding because it never came up and was not applied between 2002 and 2017?

[00:35:23] Speaker 04:
I'm not saying the FDA understood the words the same drug.

[00:35:28] Speaker 04:
Just as you said, it's in its regulations.

[00:35:31] Speaker 07:
What I'm saying is I don't see evidence on the text of the statute that Congress applied the same- Did you dispute that, though, that it was sort of common industry knowledge that such drug equals same drug under the regulatory definition?

[00:35:44] Speaker 04:
I think people know what's in the regulations.

[00:35:46] Speaker 07:
I think people understood that FDA had to... But you would have to understand... I mean, such drug was the wording that was used in subsection A, but it was being interpreted to mean same drugs as defined in the regulations.

[00:36:01] Speaker 07:
And the arguments we're getting is that everybody understood this, Congress understood it.

[00:36:06] Speaker 07:
Are you telling me that that wasn't the understanding?

[00:36:09] Speaker 04:
I'm not saying that wasn't the understanding.

[00:36:10] Speaker 04:
I'm saying that people talk, after you had a court over this, then the question is, what did Congress mean to do when it revisited this subject?

[00:36:19] Speaker 04:
What did Congress mean to do when it revisited this subject?

[00:36:20] Speaker 07:
So you don't dispute that the regulatory backdrop was that the common understanding

[00:36:25] Speaker 07:
was that such drug was being interpreted as same drug by the agency.

[00:36:28] Speaker 04:
I don't have an empirical view on what people knew.

[00:36:31] Speaker 07:
No, I'm saying that when you apply this, I guess the Monsalvo case came out and they were saying we have to look at the regulatory background and the regulatory backdrop.

[00:36:41] Speaker 07:
And I'm just asking, do you contest that the regulatory backdrop and understanding was that such drug equals same drug under the regulatory definition?

[00:36:50] Speaker 04:
It was, it was in the, it was in the regulation, that's how, how FDA defined it.

[00:36:54] Speaker 04:
I'm not disputing that in any way.

[00:36:56] Speaker 04:
And everybody, I don't know, I don't know that everyone understood that.

[00:37:00] Speaker 04:
And that's, and many people, you don't dispute that.

[00:37:03] Speaker 04:
Many people, and maybe many people disputed that it was correct.

[00:37:05] Speaker 07:
Judge Pan, what, people might dispute that it's correct, but everybody understood that that's the way the agency was doing this.

[00:37:11] Speaker 04:
And the quote, but then the question, the ratification question is, was Congress focused on

[00:37:16] Speaker 04:
this application of the same drug to break period, unexpired periods of exclusivity.

[00:37:24] Speaker 04:
Monsalvo says one, if they start with a textually plausible competition.

[00:37:32] Speaker 04:
Does days mean how many days does the Earth go around the sun?

[00:37:34] Speaker 04:
Or for filing, is the government office open?

[00:37:38] Speaker 07:
But then the critical understanding was, always the understanding was, you get the extra day after the weekend.

[00:37:45] Speaker 07:
And the parallel argument here

[00:37:47] Speaker 07:
So, the understanding was such drug equals same drug meaning clinically.

[00:37:51] Speaker 04:
And then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and then, and

[00:38:11] Speaker 04:
Does same drug fit with it?

[00:38:13] Speaker 04:
No, it doesn't.

[00:38:14] Speaker 07:
Same drug fits with the text in the context of the regulatory scheme because there's actually a definition of same drug that is consistent.

[00:38:22] Speaker 04:
But I don't think this is consistent.

[00:38:25] Speaker 04:
That's my C1 point.

[00:38:26] Speaker 07:
You're looking only at the statutory language.

[00:38:28] Speaker 07:
I'm saying, what do we do with the regulation?

[00:38:30] Speaker 04:
Right.

[00:38:32] Speaker 04:
The ratification question is, does the regulation plug into the statute in a way that makes sense in terms of text and context?

[00:38:40] Speaker 04:
I'm saying no as the context because it revolutionizes the statute.

[00:38:44] Speaker 04:
It gives the FDA broad discretion.

[00:38:47] Speaker 04:
They say there's no one general standard for a major contribution to patient care superiority, no one applicable standard.

[00:38:54] Speaker 04:
So that's an enormous amount of discretion that they give themselves in a statute that says FDA may not.

[00:38:59] Speaker 04:
And it doesn't fit with the text.

[00:39:01] Speaker 04:
It's the the FDA's language wasn't just same drug was their action language was same use same drug for the same user indication.

[00:39:11] Speaker 04:
Congress used the language same drug for the same disease or condition so they're not actually using the same action phrase that Congress.

[00:39:19] Speaker 04:
It is the drug designated under section 360 BB of this title.

[00:39:28] Speaker 04:
It's not a define.

[00:39:29] Speaker 07:
So why isn't the follow-on drug a different drug because it's clinically superior?

[00:39:33] Speaker 07:
That's different.

[00:39:35] Speaker 04:
It's the both of them.

[00:39:37] Speaker 04:
So the question is, what does ZyWave exclusivity block?

[00:39:41] Speaker 07:
I'm asking, what's your definition of same drug?

[00:39:43] Speaker 04:
The FDA is absolutely clear about this in the administrative record.

[00:39:57] Speaker 04:
The drug designated is Oxabi.

[00:40:00] Speaker 04:
That's where they designate.

[00:40:05] Speaker 04:
is also an occivate drug.

[00:40:07] Speaker 04:
And the scope of the blocking effect is determined by ZiWave's exclusivity.

[00:40:13] Speaker 04:
And again, that's crystal clear on the face of the statute.

[00:40:16] Speaker 07:
Well, the statutory language doesn't necessarily support that.

[00:40:20] Speaker 07:
If you're going to your statutory language, you just want to go to the meaning of same drug.

[00:40:23] Speaker 07:
It seems to me that the second drug is not the same because it's clinically superior.

[00:40:27] Speaker 04:
I think everyone agrees that sameness is the same in what respect.

[00:40:33] Speaker 04:
The statute tells you.

[00:40:34] Speaker 07:
And now we're going back to everyone agrees.

[00:40:36] Speaker 07:
Everyone agrees that before this amendment, such drug meant same drug.

[00:40:39] Speaker 04:
And everyone agrees that that's how FDA thought of it.

[00:40:47] Speaker 04:
The question is how Congress thought of it.

[00:40:48] Speaker 04:
It has to be how Congress thought of it.

[00:40:50] Speaker 04:
We're reading a statute, and we have to understand what the words mean in the statute.

[00:40:56] Speaker 08:
Can I come at this from a different direction?

[00:41:00] Speaker 08:
Certainly.

[00:41:03] Speaker 08:
I want you to look at 360 CCE.

[00:41:06] Speaker 08:
Sure.

[00:41:08] Speaker 08:
The demonstration of clinical superiority standard.

[00:41:12] Speaker 08:
Yes.

[00:41:13] Speaker 08:
And then there, it says that the FDA, in order to assist a sponsor, will notify that sponsor

[00:41:30] Speaker 08:
of any plausible hypothesis offered by the sponsor and relied upon the secretary that the drug is clinically superior to a previously approved drug.

[00:41:43] Speaker 08:
This is as a basis for designation, right?

[00:41:47] Speaker 08:
Yes.

[00:41:48] Speaker 08:
And this gets me back to kind of like where I started.

[00:41:53] Speaker 08:
Congress did not amend

[00:41:56] Speaker 08:
the designation section in 2017.

[00:42:02] Speaker 08:
It only, which is 360 BB, it only amended 360 CC, which is this approval.

[00:42:09] Speaker 08:
That's right.

[00:42:11] Speaker 08:
So Congress here in this subsection E is seemingly ratifying

[00:42:28] Speaker 08:
a restriction on designation that says, under some circumstances, the secretary is only going to designate a drug on a plausible hypothesis that the drug is clinically superior.

[00:42:53] Speaker 08:
Even though the designation section doesn't say anything,

[00:42:58] Speaker 08:
about a requirement of clinical superiority, right?

[00:43:04] Speaker 08:
That's right.

[00:43:05] Speaker 08:
That only comes from regulation.

[00:43:09] Speaker 04:
That's right.

[00:43:10] Speaker 04:
And so when we start you, Judge Wilkins, with the beginning of subsection E to assist sponsors in demonstrating clinical superiority as described in subsection C. So this is all about the serial exclusivity application.

[00:43:25] Speaker 04:
not the breakthrough application under A. Congress is laser focused on serial exclusivity all the way through this section, the legislative history.

[00:43:35] Speaker 08:
Well, just because it refers to subsection E, that doesn't tell me that it's referring to serial exclusivity.

[00:43:42] Speaker 08:
I mean, that just begs the question.

[00:43:45] Speaker 08:
I mean, the whole case about the subsection only to serial exclusivity for

[00:43:52] Speaker 08:
work in a break in, so to speak, an existing exclusivity here.

[00:44:00] Speaker 08:
But I guess my point is this, I'm not trying to be obtuse here, is that even though Congress only amended 360 CC,

[00:44:18] Speaker 08:
what they did impacted this other section, 360 BB, and seem to have ratified FDA's practice of saying that we're only going to designate a drug where there is an existing exclusivity period because another drug has been approved for that rare disease condition.

[00:44:48] Speaker 08:
We're only going to designate it.

[00:44:50] Speaker 08:
I'm not talking about approval.

[00:44:52] Speaker 08:
We're only going to designate it if there's at least a plausible hypothesis that this drug is clinically superior.

[00:45:02] Speaker 08:
That wasn't in the statute anywhere, but the FDA was doing that in Congress in 2017.

[00:45:10] Speaker 08:
Seemed to have kind of like blessed that regulatory structure.

[00:45:18] Speaker 04:
I think I understand, but I don't think that sheds any light on what subsection A means, because you can have a follow-on drug that may be entitled to its own period of exclusivity after

[00:45:36] Speaker 04:
a period of exclusivity is expired.

[00:45:38] Speaker 04:
So there are previously approved drugs that count under subsection C, but none of them have an existing period of exclusivity.

[00:45:47] Speaker 04:
Nonetheless, whether or not the period of exclusivity is ongoing, or rather, even if once it's expired, the question of whether there's serial exclusivity still turns on clinical superiority under C. So it's sort of once for all time,

[00:46:06] Speaker 07:
Can I ask you a question to follow up on Judge Wilkins' question?

[00:46:10] Speaker 07:
Under subsection E2, he was planning to E1?

[00:46:13] Speaker 00:
Yep.

[00:46:14] Speaker 07:
I don't understand why subsection E2 is not inconsistent with your position, because it says, upon granting exclusive approval or licensure under subsection A on the basis of a demonstration of clinical superiority, as described in subsection C, shall publish a summary of the clinical superiority findings.

[00:46:30] Speaker 07:
Doesn't that contemplate that under A, you can

[00:46:34] Speaker 07:
There's an exception for clinical superior drugs?

[00:46:37] Speaker 04:
Not at all.

[00:46:39] Speaker 04:
What you get under C1 is exclusive approval or licensure described in subsection A. And so then it's asking whether if C1 is satisfied and the agency identifies the reasons why C1 and then the clinical superior requirement C2 is satisfied.

[00:47:00] Speaker 04:
it shall publish a summary of the clinical superiority findings.

[00:47:03] Speaker 04:
It's in no way inconsistent with our reading of subsection A, which again is just a straight reading of the text and one that aligns with how the 11th Circuit understood the neighboring words in the statute for the same disease or condition and catalyst.

[00:47:19] Speaker 04:
It said, oh, well, that's obvious, just reads back to for a rare disease or condition.

[00:47:24] Speaker 04:
And so the alignment of what the district court here, how it read the same drug as ratification right next to what it then subsequently concluded in a different case called Nuralis is a refer back is really jarring.

[00:47:41] Speaker 08:
But surely- Let me just say this to kind of maybe bring this to a close, at least for my purpose.

[00:47:50] Speaker 08:
My colleague may want to continue

[00:47:54] Speaker 08:
The FDA, prior to 2017, was doing a couple of different things with exclusivity that seemed to be beyond explicit words of the statute.

[00:48:12] Speaker 08:
One was saying, we're only going to grant serial exclusivity if your drug is clinically superior

[00:48:25] Speaker 08:
And to get there, though, they restricted, not at the approval process, but at the designation step by saying, we're not going to even designate this drug unless it's clinically superior.

[00:48:46] Speaker 08:
Because if it's designated and then you get approval, you automatically get exclusivity.

[00:48:55] Speaker 08:
So the way that they were going to kind of try to like stop that from happening, you know, additional exclusivity for everybody is to say, no, we're only going to designate you in the first place if there's at least a plausible hypothesis that you're clinically superior.

[00:49:18] Speaker 08:
So that's nowhere in the statute, but that's what the FDA appeared to have been doing, right?

[00:49:25] Speaker 08:
And then the other thing it was doing that wasn't in the statute was saying, yeah, the statute says you get seven years of exclusivity.

[00:49:33] Speaker 08:
But if somebody does come along with a drug where they prove their plausible hypothesis that the drug is clinically superior

[00:49:48] Speaker 08:
We're going to give them exclusivity and break the seven-year exclusivity of the previously approved drug.

[00:49:58] Speaker 08:
We're doing both of those things, even though neither one of those is really in the statute.

[00:50:05] Speaker 08:
You say that Congress clearly blessed and ratified the first, but not the second.

[00:50:14] Speaker 08:
And my question to you is, is it

[00:50:18] Speaker 08:
These things kind of go hand in glove.

[00:50:21] Speaker 08:
So why should I find that Congress was only blessing one and not the other?

[00:50:32] Speaker 04:
A couple of points.

[00:50:32] Speaker 04:
I'm going to try to be very brief.

[00:50:35] Speaker 04:
They don't go hand in glove because they're really aiming at two different objects.

[00:50:40] Speaker 04:
The subsection C limitation, what Your Honor described as the first

[00:50:46] Speaker 04:
unblessed application of the statute, limits how many sponsors can get exclusivity without demonstrating that they've really made an innovative step.

[00:51:00] Speaker 04:
So it's a limitation on the subsection A grant of marketing exclusivity.

[00:51:07] Speaker 04:
Grant of marketing exclusivity is the inducement to come into the area

[00:51:12] Speaker 04:
in the first place.

[00:51:13] Speaker 04:
So I think it's perfectly conceivable that Congress said we want to limit subsequent grants of exclusivity for the same drug to treat the same disease or condition, because in many circumstances, there's nothing innovative going on, just blocking new entrants for no reason.

[00:51:32] Speaker 04:
But also that they would have said, this seven-year period, this is the key inducement.

[00:51:38] Speaker 04:
This is how we're bringing drugs to market.

[00:51:40] Speaker 04:
And if we don't have this, we know that many of these rare diseases will never get treatments.

[00:51:46] Speaker 04:
They're complex.

[00:51:47] Speaker 04:
The market's small.

[00:51:49] Speaker 04:
But I also want to close with this unless there are other questions.

[00:51:55] Speaker 04:
Judge Wilkins, you said something about the pre-2017 framework that's not quite right.

[00:52:00] Speaker 04:
So what FDA did was at both the designation and approval stages use the clinical superiority idea.

[00:52:08] Speaker 04:
They use the clinical superiority idea at the designation stage to say, you need to have a plausible hypothesis of why this will be clinically superior.

[00:52:17] Speaker 04:
That raised, to my understanding, no particular statutory concern because FDA had expressed rule writing authority under subsection B. And EGLE, this court said, well, you've got a lot of discretion here under subsection B. So they were using that authority.

[00:52:36] Speaker 04:
Then they turned around to the approval station and said, you've got to prove up clinical superiority.

[00:52:41] Speaker 04:
And that's what was nowhere on the statute.

[00:52:42] Speaker 04:
And my submission here, quite simply, is it's still nowhere on the statute under subsection.

[00:52:54] Speaker 06:
Thank you.

[00:52:58] Speaker 06:
Yeah.

[00:52:58] Speaker 06:
Bring them.

[00:53:13] Speaker 02:
Thank you, your honors, and may it please the court.

[00:53:16] Speaker 02:
Brian Springer on behalf of the federal government.

[00:53:18] Speaker 02:
I'd just like to pick up on the regulatory history that has been the topic of conversation this morning.

[00:53:24] Speaker 02:
For decades, FDA has recognized that determining whether two drugs are the same drug requires looking not just at the core molecule, but the other ingredients and the formulation that can make a drug clinically superior.

[00:53:38] Speaker 02:
That's always been

[00:53:40] Speaker 02:
the correct way to understand the terms used in the Orphan Drug Act, and Congress's statutory amendments in 2017 made clear what was already plain from the language.

[00:53:52] Speaker 02:
I think in this case, JAZZ seeks to equate its drug to Avidel's drug by focusing on one chemical similarity and ignoring the many consequential physical differences.

[00:54:04] Speaker 02:
Although both drugs use oxybate, JAZZ's drug

[00:54:07] Speaker 02:
is a liquid that's available for absorption immediately, while Avidel's drug uses a proprietary blend of coated and uncoated granules to facilitate a release over an extended period.

[00:54:20] Speaker 02:
And the real world effects for narcolepsy patients are profound.

[00:54:24] Speaker 02:
While narcolepsy patients have to wake up in the middle of the night to take a second dose of Jazz's drug, they can take Avidel's drug once before they go to bed.

[00:54:34] Speaker 02:
And so both in common parlance and under the statute, these drugs are not the same drug.

[00:54:40] Speaker 02:
And the differences matter for patient care.

[00:54:49] Speaker 02:
I'm happy to start wherever the court thinks would be the most helpful.

[00:54:53] Speaker 08:
But it's- Well, how is it when the statute at 360 CCA

[00:55:04] Speaker 08:
says that except as provided in subsection B, there's going to be this exclusivity period.

[00:55:12] Speaker 08:
And then subsection B has two exceptions that don't apply here.

[00:55:18] Speaker 08:
And instead, we have this condition of clinical superiority in

[00:55:33] Speaker 08:
It doesn't refer back specifically to subsection A with respect to knowing whether we're talking about a serial application as opposed to kind of breaking an exclusivity period.

[00:56:02] Speaker 08:
It would have been so much easier for Congress to have just called this an exception or made clear that notwithstanding subsection A or some sort of language like that to make clear that we're breaking an exclusivity period, but it didn't do any of it.

[00:56:28] Speaker 08:
So why should we essentially read subsections as another exception when Congress didn't call it that?

[00:56:37] Speaker 02:
So, Your Honor, I don't think it's right to call it another exception to exclusivity.

[00:56:41] Speaker 02:
This is a determination of what the scope of exclusivity is in the first instance.

[00:56:46] Speaker 02:
So subsection B is about when someone comes in with the same drug for the same disease or condition.

[00:56:53] Speaker 02:
In certain circumstances, they can break the exclusivity.

[00:56:55] Speaker 02:
They can still come onto the market, even though there's an exclusivity that's blocking them.

[00:57:00] Speaker 02:
What we're talking about here is an understanding of what is actually blocked.

[00:57:04] Speaker 02:
And that goes to the question of what is the same drug?

[00:57:08] Speaker 02:
And I would just point the court to subsection A's language.

[00:57:11] Speaker 02:
And again, this is the language that Congress adopted directly from the term that Congress took from FDA's regulations that had a definition and have had a definition for over 30 years.

[00:57:23] Speaker 02:
But if you look at subsection A, it talks about approving an application filed pursuant to section 355 of a drug designated.

[00:57:31] Speaker 02:
And then says that to the extent that that happens, FDA is prohibited from approving another application under that same section for the same drug.

[00:57:40] Speaker 02:
I mean, if you look to section 355, the analysis that FDA is doing in determining whether to approve an application is approving the whole drug.

[00:57:51] Speaker 02:
It's not focusing on just the core molecule.

[00:58:01] Speaker 08:
So you say that this is really about the scope of the exclusivity, right?

[00:58:17] Speaker 08:
Well, there had been previously, prior to 2017, a regulation

[00:58:24] Speaker 08:
on the scope of exclusivity.

[00:58:27] Speaker 08:
And I'm talking about 21 CFR 316.31.

[00:58:31] Speaker 08:
Are you familiar with that regulation?

[00:58:35] Speaker 08:
In general, yeah, I am, Your Honor.

[00:58:37] Speaker 08:
So it points out that FDA may approve a marketing application for a designated orphan drug for use in a rare disease or condition

[00:58:55] Speaker 08:
And then it says, FDA will not approve another sponsor's marketing application for the same drug for the same use or indication before the expiration of seven years, except, and then it's got these exceptions, withdrawal, consent, failure to be able to essentially meet market demand, et cetera.

[00:59:25] Speaker 08:
written in the same way as the statute in that sense, in that it lists those as exceptions.

[00:59:34] Speaker 08:
And clinically superior isn't like an exception that's in this regulation.

[00:59:49] Speaker 08:
But it's a regulation about the scope of exclusive approval.

[00:59:55] Speaker 08:
So if you're saying that this 2017 amendment was also about the scope of exclusive approval, then how

[01:00:13] Speaker 08:
Doesn't this regulation kind of undermine, I guess, your position in the sense that regulation that set forth the scope of orphan drug exclusive approval doesn't, I guess, it has to rely on the otherwise the same drug definition to get you from the regulation.

[01:00:44] Speaker 02:
It's your the reason that it leads to the same place is that the regulation that you read that says you know FDA is prohibited from among other things approving an application for the same drug.

[01:00:54] Speaker 02:
That phrase the same drug is the one that is defined in FDA is regulations to mean the same active moiety and not clinically superior.

[01:01:04] Speaker 02:
So the phrase the same drug that appears in that regulation and then that Congress added directly into the statute is defined exactly in that way to bring in the idea of clinical superiority, which is the way in ordinary parlance we think about drugs, that one that has different ingredients and a different formulation and works in a different way can be a different drug.

[01:01:31] Speaker 08:
Your friends on the other side say, though, that if you use the definition of same drug from the regulation, and you just tried to plug it into the statute, it wouldn't make sense.

[01:01:45] Speaker 08:
Because the verbiage is a little different, talking about, I think,

[01:01:57] Speaker 08:
use or indication instead of disease or condition, et cetera.

[01:02:02] Speaker 08:
What's your response to that?

[01:02:05] Speaker 02:
A couple of responses to that.

[01:02:06] Speaker 02:
I mean, I think kind of the overarching response is I don't think they actually really point to anything in A that creates a problem.

[01:02:13] Speaker 02:
They do talk about C, but the district court explained how you can understand what FDA was defining here to talk about a drug that sort of looks the same at first blush.

[01:02:24] Speaker 02:
But then you determine it's clinically superior.

[01:02:27] Speaker 02:
And therefore, it might be otherwise the same, but it's not the same drug once you determine the clinical superiority.

[01:02:34] Speaker 02:
And I understand my friends to also be talking to this separate portion of the regulation that I think Your Honor also read about same use or indication.

[01:02:43] Speaker 02:
But that sort of pertains to a different phrase, the phrase same disease or condition, which is an issue in this case.

[01:02:48] Speaker 02:
It is presented in a different case that's pending before this court.

[01:02:51] Speaker 02:
And I would encourage the court to just look at the phrase, the same drug, which again, comes directly from FDA's regulations that has long had this regulatory definition.

[01:03:04] Speaker 06:
Can I ask you just a real world question?

[01:03:08] Speaker 06:
We're in year five of Jazz's exclusivity and year two of Avedale's exclusivity, right?

[01:03:17] Speaker 06:
How does that work?

[01:03:19] Speaker 06:
Are they sharing the market?

[01:03:20] Speaker 06:
How does that work?

[01:03:23] Speaker 02:
My understanding is that in general, that's right that they're sharing the market.

[01:03:27] Speaker 02:
And that, you know, I think that I believe that jazz as exclusivity expires in 2027 and Avedale's goes until 2030.

[01:03:38] Speaker 02:
So they're both allowed to be on the market now because there was nothing that was blocking Avedale's drug from being approved, but they each have exclusivity that goes for whatever time they have.

[01:03:50] Speaker 08:
All right.

[01:03:52] Speaker 08:
I think Judge Henderson's question raises a real question.

[01:03:55] Speaker 08:
So how is it exclusivity if you're not really exclusive?

[01:04:00] Speaker 02:
Again, the question is the scope of exclusivity.

[01:04:02] Speaker 02:
And everyone, in particular because of FDA's regulations, everyone has known since at least 1992 that the right way to understand the scope of your exclusivity is that if someone comes along and develops a clinically superior drug,

[01:04:18] Speaker 02:
they can get approval and come on the market.

[01:04:20] Speaker 02:
And that's the whole point of what Congress was trying to encourage here was to have drug sponsors create drugs, create better treatments for rare diseases or conditions.

[01:04:32] Speaker 02:
And that's exactly the way that this plays out under FDA's regulatory definition.

[01:04:37] Speaker 02:
And again, the term that has now been put directly into the statute.

[01:04:43] Speaker 07:
So if there isn't exclusivity, anybody can come on the market and market the exact same, not clinically superior formulation that you're marketing?

[01:04:55] Speaker 02:
Your Honor, my understanding right is that the exclusivity is what's doing the blocking of an approval of a drug that looks the same.

[01:05:02] Speaker 07:
So it's not an orphan drug.

[01:05:03] Speaker 07:
It's just any old drug.

[01:05:04] Speaker 07:
And you get approved.

[01:05:06] Speaker 07:
People can start making generic versions of your drug immediately.

[01:05:10] Speaker 02:
I'm not sure I'm understanding.

[01:05:12] Speaker 02:
I mean, I think the answer is yes, in terms of, so this all arises just in the context of orphan drugs.

[01:05:19] Speaker 02:
And if your orphan drug is designated to treat a rare disease or condition, when you get approval, then for seven years after that, FDA can't approve a follow on.

[01:05:27] Speaker 07:
I understand how this works.

[01:05:30] Speaker 02:
Maybe I'm misunderstanding.

[01:05:32] Speaker 07:
There's some other way of protecting it.

[01:05:33] Speaker 07:
Other people can come in and start making the same thing.

[01:05:36] Speaker 02:
That's correct, Your Honor.

[01:05:37] Speaker 02:
If this protection were not there.

[01:05:41] Speaker 02:
But because the scope of it includes the idea, you know, from the phrase same drug that someone who develops something that's clinically superior can come onto the market.

[01:05:50] Speaker 02:
There's nothing.

[01:05:51] Speaker 07:
And so for these two drugs, nobody else can come in using Oxybeta unless it's clinically superior to both of them.

[01:05:56] Speaker 03:
That's correct, Your Honor.

[01:05:58] Speaker 03:
That's correct.

[01:06:01] Speaker 06:
Well, then did Ziram have to be

[01:06:03] Speaker 06:
clinically superior.

[01:06:06] Speaker 06:
It didn't did it with its serial seven-year exclusivity periods.

[01:06:12] Speaker 06:
It was either treating a different range of patients or different conditions.

[01:06:17] Speaker 02:
That's correct.

[01:06:18] Speaker 02:
It was both treating different patient populations and also it was the same sponsor who was coming back.

[01:06:24] Speaker 02:
So the same sponsor can come back.

[01:06:26] Speaker 02:
They're not blocked under the text of A.

[01:06:34] Speaker 03:
So we'd ask the court to affirm.

[01:06:35] Speaker 03:
Thank you.

[01:06:37] Speaker 06:
Let's see.

[01:06:38] Speaker 06:
Mr. Perry.

[01:06:49] Speaker 05:
May it please the court?

[01:06:50] Speaker 05:
Bill Perry for Intervener Avedale.

[01:06:56] Speaker 05:
In 2017, Congress did not silently overrule 25 years of regulatory history

[01:07:03] Speaker 05:
by choosing to adopt the precise terminology that FDA had been using throughout that term.

[01:07:09] Speaker 05:
I'd like to show how extensively Congress borrowed from FDA's regulations in 2017.

[01:07:16] Speaker 05:
Of course, we start with the phrase same drug, which appears in the key statutory provision, which is 360 CCA.

[01:07:25] Speaker 05:
But that's only the starting.

[01:07:28] Speaker 05:
What Congress did was adopt the subsidiary definitions from the regs.

[01:07:33] Speaker 08:
So it's not- Let me just interrupt you right there.

[01:07:36] Speaker 08:
Congress didn't just put in the word same drug, right?

[01:07:43] Speaker 08:
It put in the words, I'm just not sure if I have it, same drug for the same disease,

[01:07:57] Speaker 08:
That was the phrase that it used instead of such drug for such disease or condition.

[01:08:07] Speaker 05:
I'm sorry.

[01:08:09] Speaker 05:
I don't mean to cut you off.

[01:08:10] Speaker 08:
That was that key amendment.

[01:08:13] Speaker 08:
It omitted such drug for such disease or condition and substituted the same drug for the same disease.

[01:08:23] Speaker 05:
It put same in the place of such.

[01:08:26] Speaker 05:
with respect to both of those terms.

[01:08:29] Speaker 08:
But there's a phrase there.

[01:08:33] Speaker 08:
I guess I just want to get your response to the fact that

[01:08:51] Speaker 08:
like the scope of exclusivity provision that I was asking your friend about earlier, which was 316.31, uses the phrasing the same drug for the same use or indication.

[01:09:10] Speaker 08:
So it does not use the exact same phrase.

[01:09:16] Speaker 08:
Why shouldn't I be concerned about that?

[01:09:19] Speaker 05:
Because that poses a completely separate issue, not here before the court in this case.

[01:09:23] Speaker 05:
It was an issue that is use or indication or same disease and condition in the catalyst case.

[01:09:29] Speaker 05:
And here's what was at stake in that case.

[01:09:31] Speaker 05:
There was no question about it being the same drug.

[01:09:34] Speaker 05:
It was.

[01:09:36] Speaker 05:
The drug had been designated for a disease called LEMS.

[01:09:39] Speaker 05:
The second drug came along also for LEMS, but with a separate indication or use.

[01:09:45] Speaker 05:
And FDA wanted to split this notion of same disease or condition into subparts and give different exclusivities.

[01:09:55] Speaker 05:
Every drug, when it goes through this orphan drug process, as your honor knows from the designation, is identified in connection with a rare disease or condition.

[01:10:04] Speaker 05:
That's where this same disease or condition comes from.

[01:10:08] Speaker 05:
completely different for same drug.

[01:10:10] Speaker 05:
What happens at the designation stage is that you come forward and you say, I think I have a drug that I want to get approved ultimately.

[01:10:19] Speaker 05:
I want to take advantage of the various benefits Congress has provided if you're designated, including tax breaks for the development of the drug, ultimate chance at exclusivity, and all those sorts of things.

[01:10:31] Speaker 05:
Of course, you don't just identify what your active moiety is.

[01:10:35] Speaker 05:
You go through the statute and the regs and identify everything you know at that time about your drug.

[01:10:40] Speaker 05:
And then you also have to, if you're the second one along, show a plausible hypothesis of clinical superiority.

[01:10:46] Speaker 05:
That is that your drug, which you're intending to make, is going to be different than a drug that's already approved.

[01:10:51] Speaker 05:
As your honor noted, that's an E1 of CC, what Congress just did in the 2017 amendments.

[01:10:58] Speaker 05:
And so what's going on here is you have two very separate issues.

[01:11:01] Speaker 05:
One is, what does same drug mean?

[01:11:04] Speaker 05:
did when Congress in 2017 put same drug in this statute, did it mean to embrace the regulatory deficit, which I would like to say it obviously did for all the reasons I'm about to explain.

[01:11:17] Speaker 05:
But then a completely separate issue, which was addressed in Catalyst, about whether the FDA can split

[01:11:27] Speaker 05:
orphan drug designations for the same disease and condition among separate uses or indication within that same disease or condition.

[01:11:34] Speaker 05:
It can't, but it is appropriate to look at same drug the way that the regulations did.

[01:11:42] Speaker 05:
I think your question to my friend earlier was something about the exceptions.

[01:11:47] Speaker 05:
In other words, why didn't they make CCC an exception?

[01:11:51] Speaker 05:
And here's why.

[01:11:53] Speaker 05:
Because the threshold issue

[01:11:55] Speaker 05:
to get to an exception is whether two drugs are the same.

[01:11:58] Speaker 05:
When they're not the same, there's no point in going to an exception.

[01:12:01] Speaker 05:
Now, for 30-something years, FDA has operated with the definition of same drug from its regulations, which as you know is a combination of active moiety and clinically superior.

[01:12:15] Speaker 05:
The subsidiary definition of clinically superior includes significant therapeutic advantage

[01:12:20] Speaker 05:
greater efficacy, greater safety, major contribution to patient care.

[01:12:24] Speaker 05:
Every one of those terms from the FDA definitions appear in the 2017 amendments.

[01:12:30] Speaker 05:
Every one.

[01:12:31] Speaker 05:
It's not ambiguous what they were doing here.

[01:12:33] Speaker 05:
They were adopting the regulatory structure that FDA had in place.

[01:12:37] Speaker 05:
They were preserving that structure.

[01:12:40] Speaker 05:
Now, I think it's appropriate, as this Court has already done, to focus on E1 and E2 of the statute.

[01:12:45] Speaker 05:
They're very important because they show how Congress thought all these pieces would play, how they would work together.

[01:12:51] Speaker 05:
Your Honor, first identified E1, which is essentially endorsing the plausible hypothesis regulation about how the designation works, the designation stage, which is often years before the approval stage under 360 CC.

[01:13:07] Speaker 05:
You don't necessarily know what the drug is at that stage, but you still, if you're the second

[01:13:12] Speaker 05:
sponsor to come along have to show a plausible hypothesis, importantly, of clinical superiority.

[01:13:17] Speaker 05:
Congress was adopting that concept.

[01:13:19] Speaker 05:
But E2 is perhaps even more important.

[01:13:22] Speaker 05:
It tells you what Congress thought would happen under 360 CC.

[01:13:26] Speaker 05:
You're not making some separate judgment

[01:13:29] Speaker 05:
under 360CCC that you're making under 360CCA.

[01:13:35] Speaker 05:
They're tied together.

[01:13:36] Speaker 05:
Here's what it says.

[01:13:37] Speaker 05:
Upon granting exclusive approval under subsection A. That means this decision is being made under subsection A. And that in turn means that it's being made under the definition of same drug.

[01:13:51] Speaker 05:
It has to be.

[01:13:52] Speaker 05:
And then it goes on here.

[01:13:53] Speaker 05:
On the basis of a demonstration of clinical superiority as described in subsection C, what that tells us is that those two sections work together and they have to work together.

[01:14:03] Speaker 05:
And it also tells us that Congress thought subsection A and subsection C would both rely on the concept of clinical superiority, which they do.

[01:14:12] Speaker 05:
So that's not all Congress did when it adopted the regulatory text.

[01:14:17] Speaker 05:
In the statute, it uses the term otherwise the same drug a couple different times.

[01:14:22] Speaker 05:
That is a unique term that refers to this two-part definition.

[01:14:26] Speaker 05:
It appears five times in the regulations, including in the definition of clinical superiority.

[01:14:32] Speaker 05:
And it always means that there's a temporal process.

[01:14:36] Speaker 05:
First, you look and see if they have the same active moiety, and then later, after further submissions, after scientific analysis, and the court can see how this all played out in the record, in this case, you decide whether the drug is clinically superior.

[01:14:50] Speaker 05:
It might appear that the drug is the same drug as another drug when you're just looking at active moieties, but you have to run out the ground ball and do the rest of that analysis.

[01:14:58] Speaker 05:
And that's what subsections A and C do together.

[01:15:07] Speaker 05:
The case law that we've cited from the Supreme Court and this court, I think, tell us what we're supposed to do in a circumstance like this, when there's been such a huge reliance by Congress on the regulatory history.

[01:15:20] Speaker 05:
Of course, Monsalvo Velasquez, maybe two weeks ago now, says when there's a longstanding administrative construction, you generally presume Congress meant to adopt those regulations.

[01:15:31] Speaker 05:
That presumption was all but dispositive in that case.

[01:15:35] Speaker 05:
CFTC versus shore says in this type of circumstance using that regulatory construction is quote virtually conclusive that Congress meant to employ that.

[01:15:45] Speaker 05:
These are all rule cannons, rules of interpretation, presumptions.

[01:15:50] Speaker 05:
We cite four cases or three or four cases from this court over the last few years.

[01:15:56] Speaker 08:
All your friend on the other side points out that it might be pretty conclusive that

[01:16:05] Speaker 08:
They were dealing with the deployment issue, serial exclusivity regulation, as far as ratifying that.

[01:16:16] Speaker 08:
But it is far less clear that they were going beyond that.

[01:16:22] Speaker 08:
And we have precedent that says we need some more explicit clues.

[01:16:34] Speaker 05:
Let me suggest, Your Honor, that the precedent of this court and the Supreme Court are not that you need more explicit clues.

[01:16:40] Speaker 05:
In fact, often cited is Justice Scalia's treatise, Reading Law, on this point.

[01:16:47] Speaker 05:
And if I might add that to our record here, if a statute uses words or phrases that have already received authoritative construction by a responsible administrative agency, they are to be understood in accordance with that construction.

[01:17:01] Speaker 05:
That is quoted, including in HIC vision.

[01:17:03] Speaker 05:
Your Honor, Washington Alliance and Wang v Blinken, all recent cases from this court.

[01:17:10] Speaker 05:
And let me add, if I might, Your Honor, that my friend on the other side had been communicating with the FDA over multiple years before our approval about this clinical superiority issue and how the statute worked.

[01:17:24] Speaker 05:
And here's what my friend said in a letter from December of 2022 to the FDA.

[01:17:33] Speaker 05:
It's in the record at JA 382 to 383.

[01:17:35] Speaker 05:
That's the middle of the document.

[01:17:38] Speaker 05:
The document starts at JA 377.

[01:17:41] Speaker 05:
I'm just quoting here.

[01:17:44] Speaker 05:
The clear and direct command of the statute is that the only way for Avedale to break the exclusivity protecting ZyWave, it's Jazz's drug, is for Avedale to demonstrate that its drug is clinically superior.

[01:18:01] Speaker 05:
In other words, they were reading the statute two and a half years ago to have the same meeting the district court adopted here.

[01:18:08] Speaker 05:
Exactly the same meeting.

[01:18:09] Speaker 05:
After the 2017 amendments, they understood that's what this statute meant.

[01:18:13] Speaker 07:
I'm sure.

[01:18:14] Speaker 07:
Where was that?

[01:18:15] Speaker 05:
That's in a document beginning at JA 377, and the particular quote is from JA 382 to 383.

[01:18:26] Speaker 05:
Now, if I might, Your Honor, I'd like to

[01:18:30] Speaker 05:
contest one other thing that my friend on the other side says.

[01:18:33] Speaker 05:
It's about the text, the language of 360 CCA.

[01:18:40] Speaker 05:
And here, I think he believes that we will take as given that the drug designated is the first of the two comparators.

[01:18:52] Speaker 05:
You compare two drugs to each other to see if exclusivity prevents FDA from approving a second drug.

[01:18:58] Speaker 05:
The language doesn't actually say you compare the designations.

[01:19:03] Speaker 05:
Here's what it actually says.

[01:19:04] Speaker 05:
It says, if the secretary... What are you reading from now?

[01:19:07] Speaker 05:
I'm reading from... I'm sorry, I'm moving around a lot.

[01:19:10] Speaker 05:
360 CCA.

[01:19:14] Speaker 05:
So A begins, and I'm paraphrasing here because there's a lot of excess language for this purpose, but if the secretary approves an application, that's the first comparator.

[01:19:26] Speaker 05:
And then the description,

[01:19:28] Speaker 05:
in two prepositional phrases, identifies, describes what that application is for a drug designated under section 360 BB.

[01:19:38] Speaker 05:
Still, it's the application that's the subject right there.

[01:19:41] Speaker 05:
It's not the drug designated.

[01:19:44] Speaker 05:
The prepositional phrase is describing the application.

[01:19:46] Speaker 05:
And then the second comparator in that drug comparison is another application.

[01:19:54] Speaker 05:
for the same drug.

[01:19:56] Speaker 05:
In other words, you compare one application to another.

[01:19:59] Speaker 05:
That's what textually this section is telling us.

[01:20:03] Speaker 05:
You apply the same drug test, which of course comes from the rig.

[01:20:06] Speaker 05:
But let me just say this.

[01:20:09] Speaker 05:
Even if you applied the test and you used the designation, the active moiety, oxybate for the drug, for Jazz's drug, we're still different.

[01:20:22] Speaker 05:
The second comparator is still different no matter how you read the first part of that sentence.

[01:20:26] Speaker 05:
And, Your Honor, I think correctly noted the plausible hypothesis test, plausible hypothesis of clinical superiority at the designation stage.

[01:20:35] Speaker 05:
We're different because we demonstrated at that stage that we met that test.

[01:20:39] Speaker 05:
We were going to be clinically superior.

[01:20:42] Speaker 05:
And let me say there, the site in the joint appendix for that, for our designation, shows we're different.

[01:20:48] Speaker 05:
is 203 to 204 in the joint appendix.

[01:20:52] Speaker 05:
And then the explanation that will shed some light on the pretty significant amount of effort and time that FDA spent on this issue is JA 115 to 125.

[01:21:05] Speaker 05:
Here's what they were looking at.

[01:21:06] Speaker 05:
They were looking at to see if our drug had a different effect in patients' bodies

[01:21:11] Speaker 05:
That is, it might have had the same chemical, but would it affect the physiology of a patient differently?

[01:21:16] Speaker 05:
And absolutely it would.

[01:21:18] Speaker 05:
They consulted sleep experts and they looked through it.

[01:21:20] Speaker 05:
It was a major contribution to patient care.

[01:21:23] Speaker 05:
That's what makes it a different drug.

[01:21:25] Speaker 05:
That's important.

[01:21:27] Speaker 05:
But here's the third problem with my friend's analysis of the text here.

[01:21:33] Speaker 05:
I think you heard him say that if you go to section C

[01:21:37] Speaker 05:
which is the new section called condition of clinical superiority.

[01:21:40] Speaker 05:
Again, this is described in section E2.

[01:21:42] Speaker 05:
He says you can't read that section sensibly.

[01:21:47] Speaker 05:
The district court explained why you can't.

[01:21:49] Speaker 05:
It's on pages 31 and 32 of the opinion.

[01:21:52] Speaker 05:
Also, I would recommend page 30.

[01:21:54] Speaker 05:
Very important about the meaning of E2.

[01:21:57] Speaker 05:
But here's the point.

[01:21:58] Speaker 05:
If you just put my friend on the other side's test for what drug means in here, you'd be comparing oxybate

[01:22:07] Speaker 05:
and active moiety to oxyvate and active moiety to determine if oxyvate were clinically superior to oxyvate.

[01:22:14] Speaker 05:
That's nonsense.

[01:22:16] Speaker 05:
That's not how this works.

[01:22:18] Speaker 05:
The way that the same drug test works is it's got two parts.

[01:22:22] Speaker 05:
First you look at active moiety, as I said, then you turn to clinical superiority.

[01:22:25] Speaker 05:
And the question ultimately is, is this drug better for patients?

[01:22:32] Speaker 05:
Does it have a different impact on patients in their body or otherwise?

[01:22:36] Speaker 05:
There are a lot of examples in the record of drugs that had the same active moiety but were clinically superior.

[01:22:45] Speaker 05:
One that comes to mind is a drug called Valtoco where it's a treatment for people with epilepsy for cluster seizures where they need immediate relief.

[01:22:56] Speaker 05:
Same active moiety in the first drug in the second, but the second you could use through a nasal inhaler and the first was only administered rectally.

[01:23:03] Speaker 05:
And the court, sorry,

[01:23:06] Speaker 05:
The FDA found that was a really significant difference.

[01:23:09] Speaker 05:
It made it a different and much better drug.

[01:23:12] Speaker 05:
So this is not only the right test because it adopts very clearly, Congress is very clearly to adopt the regulatory structure that had been preexisting, but it's also the best reading of the statute.

[01:23:24] Speaker 05:
You can't just say that because two drugs have the same active moiety, I'm going to ignore all the inactive ingredients and how these actually work in the body.

[01:23:32] Speaker 05:
They're the same drug.

[01:23:33] Speaker 05:
They're not.

[01:23:34] Speaker 05:
And you can't just say any slight difference, an immaterial difference between one drug's application, maybe an inactive ingredient, always makes this a different drug because that undermines exclusivity.

[01:23:47] Speaker 05:
What FDA did was find the sweet spot where you're talking about the effect on patients.

[01:23:54] Speaker 05:
That is the best reading of this statute.

[01:23:57] Speaker 05:
And that's what Congress recognized in 2017 when it widely adopted the statutory text.

[01:24:02] Speaker 05:
I'm sorry, the regulatory text into the statute.

[01:24:05] Speaker 06:
All right.

[01:24:06] Speaker 06:
If there are no questions, then thanks, John.

[01:24:08] Speaker 05:
Thank you.

[01:24:20] Speaker 06:
I'm going to hold you to two minutes.

[01:24:22] Speaker 04:
That's more than fair, your honor.

[01:24:25] Speaker 04:
I have a methodological point, a statutory point, and then a same drug comparison point that I'm going to close with.

[01:24:32] Speaker 04:
On methodology, I'm going to go with Justice Scalia at the Supreme Court over Justice Scalia in a book.

[01:24:39] Speaker 04:
Johnson versus United States says that if you're going to consider ratification, you have to make sure that it fits the context.

[01:24:47] Speaker 04:
Yon says exactly the same thing.

[01:24:49] Speaker 04:
And that's why this is ultimately a question of how you read the statute that Congress wrote, not the regulation that FDA wrote.

[01:24:58] Speaker 04:
And you have to, before you can take the step of saying,

[01:25:01] Speaker 04:
They must have absorbed it into what they were thinking.

[01:25:04] Speaker 04:
If they ask whether it fits, here it would revolutionize the statute.

[01:25:08] Speaker 04:
It would untie the agency's hands with a couple of words.

[01:25:13] Speaker 04:
On the couple of words, Judge Wilkins, I think you're exactly right to point to how FDA had defined scope of orphan drug approval.

[01:25:22] Speaker 04:
That's the action language I was talking about earlier.

[01:25:24] Speaker 04:
FDA used the words the same drug for the same user indication.

[01:25:30] Speaker 04:
The statute doesn't use those words.

[01:25:33] Speaker 04:
I understand there's a catalyst versus jazz point, but the point is, for these purposes, they're saying you got to just read it as though Congress absorbed everything the agency had done.

[01:25:45] Speaker 04:
But Congress used different words for exactly the same thing.

[01:25:49] Speaker 04:
What's the scope of orphan drug approval?

[01:25:51] Speaker 07:
And address the parent concession and the record that was pointed to by your friend and the other side at 382 to 383.

[01:25:59] Speaker 07:
I guess this is a document signed by you.

[01:26:01] Speaker 07:
And it says the only way for AVIDL to break the ODE protecting ZyWave would be for AVIDL to demonstrate.

[01:26:09] Speaker 07:
that it's clinically superior?

[01:26:11] Speaker 04:
It is.

[01:26:12] Speaker 04:
That's what we said.

[01:26:12] Speaker 04:
And then we took it back.

[01:26:14] Speaker 04:
We subsequently argued to the agency.

[01:26:17] Speaker 04:
Actually, there's no statutory authority for this.

[01:26:19] Speaker 04:
That's why it's addressed in the agency letter and all the way up.

[01:26:24] Speaker 04:
On the same drug comparison, Mr. Perry makes a point.

[01:26:34] Speaker 04:
He says, well, even if you read same drug as referring back up, the two drugs are different.

[01:26:40] Speaker 04:
They're not oxidate.

[01:26:41] Speaker 04:
That's not how FDA designates.

[01:26:43] Speaker 04:
Our reply brief at page 15 addresses the way that FDA designates and also FDA's own explanation of why they at one point used sodium oxidate for extended release oral suspension, the JA203 site, to describe the designation.

[01:27:02] Speaker 04:
FDA explained that.

[01:27:04] Speaker 04:
And so finally, just to come home, if you look at subsection A and you ask yourself, did Congress rewrite this provision of the statute to create a new exception that hadn't been there before?

[01:27:14] Speaker 04:
The Judge Jackson had told them, isn't there?

[01:27:17] Speaker 04:
You only see a portion of an overlap between how FDA had described scope of orphan drug approval and how FDA defined the term.

[01:27:27] Speaker 04:
That's not enough under any precedent in this court or this group.

[01:27:31] Speaker 04:
Thank you.